Evidence map›Paper›PMID 38388239›Full record

ArticleVaccine2024

Mortality risk after COVID-19 vaccination: A self-controlled case series study.

Stanley Xu, Lina S Sy, Vennis Hong, Paddy Farrington, Sungching C Glenn, Denison S Ryan, Abraelle M Shirley, Bruno J Lewin, Hung-Fu Tseng, Gabriela Vazquez-Benitez and 9 more

Abstract read
In one paragraph

Article in Vaccine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Stanley XuResearch and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States; Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, CA, United States. Electronic address: Stan.Xu@kp.org.
Lina S SyResearch and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
Vennis HongResearch and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
Paddy FarringtonSchool of Mathematics and Statistics, The Open University, Milton Keynes, UK.
Sungching C GlennResearch and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
Denison S RyanResearch and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
Abraelle M ShirleyResearch and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
Bruno J LewinResearch and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
Hung-Fu TsengResearch and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
Gabriela Vazquez-BenitezHealthPartners Institute, Minneapolis, MN, United States.
Jason M GlanzInstitute for Health Research, Kaiser Permanente Colorado, Denver, CO, United States; Department of Epidemiology, University of Colorado School of Public Health, Aurora, CO, United States.
Bruce FiremanKaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, CA, United States.
David L McClureMarshfield Clinic Research Institute, Marshfield, WI, United States.
Laura P HurleyDenver Health, Denver, CO, United States.
Onchee YuKaiser Permanente Washington Health Research Institute, Kaiser Permanente Washington, Seattle, WA, United States.
Michael WerneckeAcumen LLC, Burlingame, CA, United States.
Ning SmithCenter for Health Research, Kaiser Permanente Northwest, Portland, OR, United States.
Eric S WeintraubImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Lei QianResearch and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.

Funding

CDC HHS 75D30122D15425Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundAlthough previous studies found no-increased mortality risk after COVID-19 vaccination, residual confounding bias might have impacted the findings. Using a modified self-controlled case series (SCCS) design, we assessed the risk of non-COVID-19 mortality, all-cause mortality, and four cardiac-related death outcomes after primary series COVID-19 vaccination.

methodsWe analyzed all deaths between December 14, 2020, and August 11, 2021, among individuals from eight Vaccine Safety Datalink sites. Demographic characteristics of deaths in recipients of COVID-19 vaccines and unvaccinated individuals were reported. We conducted SCCS analyses by vaccine type and death outcomes and reported relative incidences (RI). The observation period for death spanned from the dates of emergency use authorization to the end of the study period (August 11, 2021) without censoring the observation period upon death. We pre-specified a primary risk interval of 28-day and a secondary risk interval of 14-day after each vaccination dose. Adjusting for seasonality in mortality analyses is crucial because death rates vary over time. Deaths among unvaccinated individuals were included in SCCS analyses to account for seasonality by incorporating calendar month in the models.

resultsFor Pfizer-BioNTech (BNT162b2), RIs of non-COVID-19 mortality, all-cause mortality, and four cardiac-related death outcomes were below 1 and 95 % confidence intervals (CIs) excluded 1 across both doses and both risk intervals. For Moderna (mRNA-1273), RI point estimates of all outcomes were below 1, although the 95 % CIs of two RI estimates included 1: cardiac-related (RI = 0.78, 95 % CI, 0.58-1.04) and non-COVID-19 cardiac-related mortality (RI = 0.80, 95 % CI, 0.60-1.08) 14 days after the second dose in individuals without pre-existing cancer and heart disease. For Janssen (Ad26.COV2.S), RIs of four cardiac-related death outcomes ranged from 0.94 to 0.98 for the 14-day risk interval, and 0.68 to 0.72 for the 28-day risk interval and 95 % CIs included 1.

conclusionUsing a modified SCCS design and adjusting for temporal trends, no-increased risk was found for non-COVID-19 mortality, all-cause mortality, and four cardiac-related death outcomes among recipients of the three COVID-19 vaccines used in the US.

Indexed as

COVID-19COVID-19 VaccinesAd26COVS1BNT162 VaccineHumansResearch DesignVaccinationAd26COVS1BNT162 VaccineCOVID-19 VaccinesAll-cause mortalityCardiac-related mortalityCOVID-19 vaccinesnon-COVID-19 mortalitySelf-controlled case series

Identifiers

PMID38388239
PMCPMC11238073

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.